Knowledge Hub Article
21st May, 2018
by Bruce Lovell
Furniture and the Medical Devices Directive (MDD) 93/42/EEC - Guidance and CE marking requirements.
At a glance:
The Medical Devices Directive (MDD) has an extremely broad remit, and covers all products/equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. It is important to understand that the intended purpose and the way a product is marketed can cause them to be covered or excluded from this directive.
Where other directives look at eliminating or reducing risk of injury the MDD takes a different view, balancing risk against benefit. Effectively the MDD accepts that some products might pose a health risk to the user, but it is outweighed by the benefits.
- How to classify your products based on their intended usage
- Guidance on what all products must be subject to (regardless of their classification)
- Understand what ‘technical information’ you need to state with the product
- Explanations of ‘EC Declaration of Conformity’ and ‘CE Marking’
- See what standards are associated with these products